Study on Stereotactic Radiosurgery vs. Whole Brain Radiation Therapy for Treating Non-Melanoma Brain Metastases

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0

ClinicalTrials ID:NCT01592968

Provider View

This clinical trial is comparing two types of radiation therapy to see which works better for treating non-melanoma cancer that has spread to the brain. The study will also look at how these treatments affect thinking and memory.

Patient Parameters

Program Overview

This study is testing two different radiation treatments for patients with non-melanoma cancer that has spread to the brain. One treatment, called stereotactic radiosurgery (SRS), uses a high dose of radiation aimed directly at the tumor, which may kill more cancer cells and cause less damage to healthy tissue. The other treatment, whole brain radiation therapy (WBRT), delivers a lower dose of radiation to the entire brain over several sessions. Researchers want to find out which treatment is more effective and whether SRS causes fewer problems with thinking and memory than WBRT.

Description

The main goal of this study is to compare how well stereotactic radiosurgery (SRS) and whole brain radiation therapy (WBRT) control brain tumors in patients with 4 to 15 non-melanoma brain metastases. Researchers will also compare the effects of these treatments on memory and thinking skills four months after treatment.

Secondary goals include checking how well the treatments control tumors in the brain over time, measuring overall survival, and assessing changes in memory and other cognitive functions at different times after treatment. The study will also look at factors like age and overall health to see how they affect treatment outcomes.

Participants will be randomly assigned to one of two groups. One group will receive SRS, which involves a single high-dose radiation treatment. The other group will receive WBRT, which involves multiple lower-dose treatments over two weeks. After treatment, participants will have follow-up visits at 1, 4, 6, 9, and 12 months to monitor their health and the effects of the treatment.

Eligibility Criteria

Inclusion Criteria

  • Must have a confirmed diagnosis of cancer that has spread to the brain, with 4 to 15 brain tumors visible on an MRI scan.
  • Must be 18 years or older.
  • Must sign a consent form to participate in the study.
  • Must be able to have all brain tumors treated with SRS, with the largest tumor being less than 3.5 cm in size.
  • Must have good liver, kidney, and blood function based on specific medical tests.
  • Must have normal blood clotting and be able to stop blood-thinning medications around the time of treatment.
  • May be receiving other cancer treatments, like chemotherapy, as decided by their doctor.

Exclusion Criteria

  • Cannot have melanoma, small cell lung cancer, lymphoma, leukemia, or germ cell tumors.
  • Cannot have had surgery to remove brain tumors.
  • Cannot have cancer that has spread to the lining of the brain or spinal cord.
  • Cannot have had whole brain radiation therapy or preventive brain radiation before.
  • Cannot be pregnant.
  • Cannot have fewer than 4 or more than 15 brain tumors at the start of the study, or more than 20 tumors at the time of treatment planning.
  • Must be able to have an MRI scan.

Locations

FACILITYZIPCITYSTATE
M D Anderson Cancer Center77030HoustonTexas

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